A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles

NCT07779941 | Not Yet Recruiting

• 1 other identifier: 2025-2058
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study. Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place. This study will compare two types of commonly used spectacle lenses: ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision. Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision. By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses: reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.

Conditions

Myopia; Pre-myopia

Keywords

myopia; pre-myopia

Outcome Measures

Primary Outcomes (1)

• Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.

  12 months of wear

Secondary Outcomes (7)

• Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.

  12 months

• Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.

  12 months

• Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months

  12 months

• Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.

  12 months

• Number of participants with adverse events related to ZEISS MyoActive spectacle lens wear compared to single vision lenses at 12 months.

  12 months

Study Arms (2)

Placebo

SHAM COMPARATOR

Participants will be provided with a pair of spectacles fitted with plano single vision lenses according to the assigned study intervention.

Device: Single Vision Lenses

Zeiss MyoActive Lenses

EXPERIMENTAL

Participants will be provided with a pair of spectacles fitted with plano MyoActive lenses according to the assigned study intervention.

Device: Zeiss MyoActive lenses

Interventions

Zeiss MyoActive lenses DEVICE

The novel ZEISS MyoActive lens was designed to introduce simultaneous myopic defocus at the retina. Early studies, including interim results from the ongoing trial NCT06563700, have shown promise in reducing myopia progression in already-myope children. However, its utility in pre-myopic children remains underexplored, and no current optical strategy has been validated for delaying the transition from pre-myopia to clinical myopia.

Zeiss MyoActive Lenses

Single Vision Lenses DEVICE

Patients will be fitted with a pair of plano single vision glasses.

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants enrolled in the trial must:
• be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
• be able to understand and participate in the Assent process;
• at baseline, be within the age range of 6 to 12 years old inclusive;
• No prior spectacle correction
• Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D
• Astigmatism of less than -1.50D
• Anisometropia of not more than 1.50D
• At least 1 parent or more with myopia

You may not qualify if:

• Participants enrolled in the trial must NOT have:
• Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the study. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.
• History of eye trauma
• Amblyopia
• Strabismus
• History of any form of optical correction
• Any concomitant myopia control treatment including atropine eyedrops, contact lenses or other myopia control glasses.
• The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participant's best interests.

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: collaborator
• ZEISS Vision Care: collaborator
• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

Location

Related Publications (5)

• Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958.

  PMID: 30817829 BACKGROUND

• Bullimore MA, Saunders KJ, Baraas RC, Berntsen DA, Chen Z, Chia AWL, Goto S, Jiang J, Lan W, Logan NS, Najjar RP, Polling JR, Read SA, Woodman-Pieterse EC, Szell N, Verkicharla PK, Wu PC, Zhu X, Loughman J, Nagra M, Phillips JR, Tran HDM, Vera-Diaz FA, Yam J, Liu YM, Singh SE, Wildsoet CF. IMI-Interventions for Controlling Myopia Onset and Progression 2025. Invest Ophthalmol Vis Sci. 2025 Sep 2;66(12):39. doi: 10.1167/iovs.66.12.39.

  PMID: 40960225 BACKGROUND

• Sankaridurg P, Berntsen DA, Bullimore MA, Cho P, Flitcroft I, Gawne TJ, Gifford KL, Jong M, Kang P, Ostrin LA, Santodomingo-Rubido J, Wildsoet C, Wolffsohn JS. IMI 2023 Digest. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):7. doi: 10.1167/iovs.64.6.7.

  PMID: 37126356 BACKGROUND

• Sankaridurg P, Tahhan N, Kandel H, Naduvilath T, Zou H, Frick KD, Marmamula S, Friedman DS, Lamoureux E, Keeffe J, Walline JJ, Fricke TR, Kovai V, Resnikoff S. IMI Impact of Myopia. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):2. doi: 10.1167/iovs.62.5.2.

  PMID: 33909036 BACKGROUND

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Dr Foo Li Lian

CONTACT

+6596572880; foo.li.lian@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Myopia Service, Singapore National Eye Centre, Myopia Centre of Excellence Singapore Clinical Assistant Professor, DUKE-NUS Graduate Medical School Consultant Ophthalmologist, Singapore National Eye Centre Myopia Program Lead, SNEC

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)